Haematological MalignanciesPhase 1NCT01336478
CD56+CD3- NK Cells Following Allogeneic Stem Cell Transplantation
A Phase 1 study testing Infusion of donor derived ex-vivo selected NK cells to patients after transplant and Haematology / Blood chemistry sampling in people with Haematological Malignancies and Allogeneic Stem Cell Transplant, run by Imperial College London at 1 site in United Kingdom.
Trial summary
The investigators propose a nonrandomized, Phase I study to assess the safety of infusion of NK cells that will be selected from sibling donors and infused to patients with hematological malignancies early following allogeneic stem cell transplantation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Haematological Malignancies, Allogeneic Stem Cell Transplant, CD56+CD3- NK Cells
- What is being tested?
- Infusion of donor derived ex-vivo selected NK cells to patients after transplant and Haematology / Blood chemistry sampling
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2011to Jun 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients undergoing an allogeneic HSCT from a sibling donor, as treatment for a hematological malignancy. The conditioning regimen, and in particular whether ablative or non ablative, will not be considered in the criteria for recruitment
- Patient and donor Age >18 years
- Patients and donors must have signed an informed consent form
- The donor must be willing and capable of donating lymphocytes for NK selection using apheresis techniques
- Donor must be fit to undergo leukapheresis
Who cannot join
- Life expectancy < 3 months
- ECOG performance status 3 or 4
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, life threatening cardiac arrhythmia
- Patients will not be eligible if they receive in vivo T depletion with ATG, ALG or campath-1H
- HIV-positive patients
- Psychiatric illness/social situations that would limit compliance with study requirements and ability to comprehend the investigational nature of the study and provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Toxicity of Escalating Doses of Adoptively Infused ex Vivo Selected CD56+CD3- NK Cells on Day 7 Following Allogeneic Stem Cell Transplantation in Patients With Hematological Malignancies.
The investigators propose a nonrandomized, Phase I study to assess the safety of infusion of NK cells that will be selected from sibling donors and infused to patients with hematological malignancies early following allogeneic stem cell transplantation.
Read the detailed description
Allogeneic hematopoietic stem cell transplantation (HSCT) is a very effective treatment for a number of hematological malignancies but relapse remains a major problem, especially in patients with high risk disease. Natural killer (NK) cells are immune cells that recognize and kill virally infected cells and tumor cells. NK cells are identified by the expression of the CD56 surface antigen and the lack of CD3. Their ability to kill tumor cells makes them promising to evaluate as effector cells for immunotherapy.
- Being tested
- Infusion of donor derived ex-vivo selected NK cells to patients after transplant, Haematology / Blood chemistry sampling
- Keywords
- NK, natural killer, immunotherapy, leukemia, hematological malignancies, stem cell transplantation, adoptive therapy
- Medical subject headings
- Leukemia, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infusion of donor derived ex-vivo selected NK cells to patients after transplantProcedure or surgery
Infusion of donor derived ex-vivo selected NK cells to patients after transplant
Haematology / Blood chemistry samplingProcedure or surgery
Haematology / Blood chemistry sampling, collection of blood for ancillary lab research
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and toxicity donor CD56+CD3- NK cells
To evaluate the safety and toxicity of escalating doses of ex vivo selected donor CD56+CD3- NK cells, adoptively infused on day 7 following sibling allogeneic stem cell transplantation in patients with hematological malignancies. We will specifically look for the proportion of patients who develop infusion related toxicity. Toxicity will be defined as per the Common Terminology Criteria for Adverse Events v3.0 (CTCAE).
Measured: Day 28 post NK cell infusion
Secondary outcomes (3)
Donor neutrophil and platelet engraftment
Donor neutrophil engraftment (Neut > 0.5 x10^9/L) and platelet engraftment (Plt > 20 x10^9/L)
Measured: Day 28 post stem cell infusion
Rates of acute GVHD (grade 2-4)
Risk of acute GVHD
Measured: Day 100 post stem cell infusion
Relapse rate
Relapse
Measured: 1 year post stem cell infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionJun 2014 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Haematological MalignanciesStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katy Rezvani, MD, Principal investigator, Imperial College Healthcare NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01336478
- Sponsor's protocol ID
- JROHH0203
- Status last verified
- Mar 2012
- First submitted
- 22 Mar 2011
- Last updated
- 8 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Toxicity of Escalating Doses of Adoptively Infused ex Vivo Selected CD56+CD3- NK Cells on Day 7 Following Allogeneic Stem Cell Transplantation in Patients With Hematological Malignancies.
- ClinicalTrials.gov ID
- NCT01336478
- Acronym / sponsor ID
- JROHH0203
- Keywords
- NK, natural killer, immunotherapy, leukemia, hematological malignancies, stem cell transplantation, adoptive therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 18 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators propose a nonrandomized, Phase I study to assess the safety of infusion of NK cells that will be selected from sibling donors and infused to patients with hematological malignancies early following allogeneic stem cell transplantation.
Detailed description
Allogeneic hematopoietic stem cell transplantation (HSCT) is a very effective treatment for a number of hematological malignancies but relapse remains a major problem, especially in patients with high risk disease. Natural killer (NK) cells are immune cells that recognize and kill virally infected cells and tumor cells. NK cells are identified by the expression of the CD56 surface antigen and the lack of CD3. Their ability to kill tumor cells makes them promising to evaluate as effector cells for immunotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients undergoing an allogeneic HSCT from a sibling donor, as treatment for a hematological malignancy. The conditioning regimen, and in particular whether ablative or non ablative, will not be considered in the criteria for recruitment
- Patient and donor Age >18 years
- Patients and donors must have signed an informed consent form
- The donor must be willing and capable of donating lymphocytes for NK selection using apheresis techniques
- Donor must be fit to undergo leukapheresis
Key exclusion criteria (6 listed)
- Life expectancy < 3 months
- ECOG performance status 3 or 4
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, life threatening cardiac arrhythmia
- Patients will not be eligible if they receive in vivo T depletion with ATG, ALG or campath-1H
- HIV-positive patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infusion of donor derived ex-vivo selected NK cells to patients after transplantInfusion of donor derived ex-vivo selected NK cells to patients after transplant | Procedure or surgery | – |
| Haematology / Blood chemistry samplingHaematology / Blood chemistry sampling, collection of blood for ancillary lab research | Procedure or surgery | – |
Primary outcome
Safety and toxicity donor CD56+CD3- NK cells
Time frame: Day 28 post NK cell infusion
To evaluate the safety and toxicity of escalating doses of ex vivo selected donor CD56+CD3- NK cells, adoptively infused on day 7 following sibling allogeneic stem cell transplantation in patients with hematological malignancies. We will specifically look for the proportion of patients who develop infusion related toxicity. Toxicity will be defined as per the Common Terminology Criteria for Adverse Events v3.0 (CTCAE).
3 secondary outcomes
Donor neutrophil and platelet engraftment
Time frame: Day 28 post stem cell infusion
Rates of acute GVHD (grade 2-4)
Time frame: Day 100 post stem cell infusion
Relapse rate
Time frame: 1 year post stem cell infusion
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katy Rezvani, MD principal investigator
Imperial College Healthcare NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Infusion of donor derived ex-vivo selected NK cells to patients after transplant and Haematology / Blood chemistry sampling in people with Haematological Malignancies and Allogeneic Stem Cell Transplant, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and toxicity donor CD56+CD3- NK cells (time frame: Day 28 post NK cell infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2015.